FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2172855
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-09939
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- March 31, 2011
- Report Date
- June 8, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED WITH NORMAL MEASUREMENTS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD EXHIBITED HIGH SHOCK IMPEDANCES DUE TO AN ERROR IN PROGRAMMING. IT WAS NOTED THAT THE SHOCK VECTOR HAD BEEN PROGRAMMED RV-SVC + CAN IN A SINGLE COIL LEAD. THE SHOCK VECTOR WAS REPROGRAMMED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PACING SYSTEM REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |